Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000279123
Ethics application status
Approved
Date submitted
14/02/2019
Date registered
25/02/2019
Date last updated
25/02/2019
Date data sharing statement initially provided
25/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE KNEE STRESS TEST: a proposed test for assessing patient outcomes following knee replacement using a bicycle power meter
Scientific title
THE KNEE STRESS TEST: a proposed test for assessing patient outcomes in knee arthroplasty
using a bicycle power meter
Secondary ID [1] 297418 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee arthroplasty 311587 0
Knee osteoarthritis 311588 0
Condition category
Condition code
Musculoskeletal 310217 310217 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 310218 310218 0 0
Other physical medicine / rehabilitation
Surgery 310292 310292 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assess muscle function using a power meter attached to a stationary bicycle in participants undergoing total knee arthroplasty surgery. Muscle power will be assessed pre-operatively and post-operatively at 3 months, 6 months and 12 months to determine the reliability and validity of the power meter testing protocol in this patient population.

At each assessment participants will undergo a routine physical examination by an Orthopaedic Surgeon or Physiotherapist to ensure they have adequate range of movement and physical ability to operate the bicycle. The participants will be asked to complete the OKS and KOOS questionnaires. The bicycle power assessment and the performance-based outcome measures (10MWT and 30sSTS) will then be completed with assistance from the physiotherapist. The participants will be asked whether they have pain when completing the 10MWT, 30sSTS and bicycle power assessment, and if applicable a score from 0 to 10 for their level of pain, with 0 being no pain. The bicycle power assessment will consist of a 1-minute warm-up, followed by three sprint phases of 10 seconds (maximal exertion) with 1-minute recovery phases in between.

Total duration of the assessments is approximately 30 minutes pre-operatively and 20 mins post-operatively at 3,6 and 12 months.
Intervention code [1] 313665 0
Not applicable
Comparator / control treatment
We will also assess muscle function in healthy participants on two occasions to determine the reliability of the power meter testing protocol. The testing occasions will be 1 week apart.
Control group
Active

Outcomes
Primary outcome [1] 319100 0
Maximum power output (watts) using the InfoCrank Power Meter (Verve Cycling, AUS). This information is read by a O_Synce Navi2coach bike computer (Verve Cycling, AUS). Data is then transferred to a cycling analysis software program, Golden Cheetah for Windows (GoldenCheetah v3.4).
Timepoint [1] 319100 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op (primary endpoint)
Primary outcome [2] 319101 0
Average power output (watts) using the InfoCrank Power Meter (Verve Cycling, AUS). This information is read by a O_Synce Navi2coach bike computer (Verve Cycling, AUS). Data is then transferred to a cycling analysis software program, Golden Cheetah for Windows (GoldenCheetah v3.4).
Timepoint [2] 319101 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op (primary endpoint)
Secondary outcome [1] 366973 0
Self-reported knee function using the Oxford Knee Score (OKS)
Timepoint [1] 366973 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op
Secondary outcome [2] 366974 0
Self reported knee function using the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [2] 366974 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op
Secondary outcome [3] 366975 0
Walking speed (m/sec) using the 10 meter walk test
Timepoint [3] 366975 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op
Secondary outcome [4] 366976 0
Leg strength and endurance using the 30 second sit-to-stand test
Timepoint [4] 366976 0
Pre-operatively, 3 months post-op, 6 months post-op and 12 months post-op

Eligibility
Key inclusion criteria
Total Knee Arthroplasty Participants:
-Adult participants greater than 18 years of age
-Participants undergoing a unicompartmental or total knee replacement by a study investigor.

Control Participants:
-Adult participants greater than 18 years of age
-No current or previous episodes of knee pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Total Knee Arthroplasty Participants:
-Participants with poor English who are unable to complete the questionnaires and understand instructions
-Participants who are physically unable to mount bicycle (severe pain, non-ambulant)
-Participants with a <90 degree knee range of movement or significant stiffness as diagnosed by the Orthopaedic Surgeon or Physiotherapist
-Participants with an unstable cardiovascular or respiratory condition
-Participants with a height greater than or equal to 6’3” (190.5cm)
-Participants with a weight greater than or equal to 108.5kg

Control Participants:
-Previous lower limb surgery
-Participants with an unstable cardiovascular or respiratory condition

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All participants eligible for inclusion in this study will be included in the data analysis. Descriptive statistics will be reported. Linear mixed model regression will be used to assess whether strength improves post TKA, including participant as a random factor to account for the correlation inherent in a repeated measures design. The association between objective power, subjective measures of knee function and performance-based testing will also be explored using regression analyses. All models will also include potential confounding factors as covariates (e.g. age, gender etc) when applicable. A significance level will be set at P<0.05. A total of 90 participants will be recruited as per our power calculation. Test-retest reliability will be assessed using the ICC from a 2 way mixed model with the absolute agreement definition. The variability in the measure will be further described using the standard error of measurement and minimum detectable difference. A total of 20 control participants will be recruited as per our power calculation.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/09/2017
Date of last participant enrolment
Anticipated
12/07/2019
Actual
Date of last data collection
Anticipated
12/07/2020
Actual
Sample size
Target
110
Accrual to date
57
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301985 0
Hospital
Name [1] 301985 0
St John of God Murdoch Hospital
Country [1] 301985 0
Australia
Primary sponsor type
Hospital
Name
St John of God Murdoch Hospital
Address
St John of God Murdoch Hospital
100 Murdoch Drive, Murdoch,
WA, 6150
Country
Australia
Secondary sponsor category [1] 301767 0
Individual
Name [1] 301767 0
Mr Mark Hurworth
Address [1] 301767 0
Murdoch Orthopaedic Clinic
Suite 10
100 Murdoch Drive, Murdoch
WA 6150
Country [1] 301767 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302664 0
St John of God Healthcare Human Research Ethics Committee
Ethics committee address [1] 302664 0
Ethics committee country [1] 302664 0
Australia
Date submitted for ethics approval [1] 302664 0
Approval date [1] 302664 0
14/07/2017
Ethics approval number [1] 302664 0
1196

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90986 0
Mr Mark Hurworth
Address 90986 0
Murdoch Orthopaedic Clinic
Suite 10/100 Murdoch Drive
Murdoch WA 6150
Country 90986 0
Australia
Phone 90986 0
+61 863326332
Fax 90986 0
Email 90986 0
[email protected]
Contact person for public queries
Name 90987 0
Rebekah Gibbons
Address 90987 0
Murdoch Centre for Orthopaedic Research
Lower Ground Research Hub
St John of God Murdoch Hospital
100 Murdoch Drive, Murdoch
WA, 6150
Country 90987 0
Australia
Phone 90987 0
+61 894389007
Fax 90987 0
Email 90987 0
[email protected]
Contact person for scientific queries
Name 90988 0
Rebekah Gibbons
Address 90988 0
Murdoch Centre for Orthopaedic Research
Lower Ground Research Hub
St John of God Murdoch Hospital
100 Murdoch Drive, Murdoch
WA, 6150
Country 90988 0
Australia
Phone 90988 0
+61 894389007
Fax 90988 0
Email 90988 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.